ICU sedation, delirium & recovery

Targeted Temperature Management at 35°C vs. 37°C for Heatstroke in ICU: A Pilot Randomized Controlled Trial

Crit Care MedPublished Randomised controlled trial

Authors' conclusion

This pilot study confirms the operational feasibility of a large-scale randomized clinical trial. However, therapeutic hypothermia was associated with significantly worse gastrointestinal injury and higher arrhythmia incidence, without evidence of neurologic or survival benefit.

Study context

Population
Intubated adults (18 yr or older) with heatstroke, 10 tertiary ICUs in China
Participants
35 adults
Comparison
Targeted temperature management (TTM) at 35°C vs controlled normothermia
Primary endpoint
Feasibility (recruitment rate, retention rate, protocol adherence)
Methodological detailspilot, multicentre
  • Pilot
  • Multicentre

Primary result

As reported in the abstract

Feasibility

Recruitment rate

83.7%

Retention rate

97.2%

Protocol adherence

exceeded 88%

Further findings

28-day poor functional outcome

No significant difference, 28-day poor functional outcome (therapeutic hypothermia vs controlled normothermia)
17.6% vs. 16.7%

Survival · 28 days

No significant difference, survival (therapeutic hypothermia vs controlled normothermia)
82.4% vs. 83.3%

Safety

Severe gastrointestinal injury (Acute Gastrointestinal Injury grade 3-4)

Significantly higher with therapeutic hypothermia vs controlled normothermia
52.9% vs. 0%
  • p < 0.001

Arrhythmias

Significantly higher with therapeutic hypothermia vs controlled normothermia
41.2% vs. 11.1%
  • p = 0.045

Lytic cocktail required (rescue for refractory shivering)

Hypothermia vs normothermia
100% vs. 27.8%
  • p < 0.001

Original publication

Targeted Temperature Management at 35°C vs. 37°C for Heatstroke in ICU: A Pilot Randomized Controlled Trial. Crit Care Med. Published 6 August 2026. doi:10.1097/ccm.0000000000007266

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